Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04987203 | Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma | PHASE3 | ACTIVE NOT_RECRUITING | 343 | — | — | Sep 9, 2021 | Dec 30, 2025 | Aug 22, 2025 | 139 | United States, Argentina +14 |
Comparison of the PFS of tivozanib in combination with nivolumab to tivozanib in subjects with RCC who have progressed following 1 or 2 lines of therapy. PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease \[PD\], radiological) according to Response Evaluation Criteria In Solid Tumors (RECIST), or death due to any reasons whichever comes first.
| Arm | Type | Description |
|---|---|---|
| Tivozanib in Combination with Nivolumab | EXPERIMENTAL | Subjects with advanced RCC will receive 0.89 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug and nivolumab every 4 weeks on Day 1 of each Cycle, until disease progression or unacceptable toxicities occur, other withdrawal criteria are met, or completion of 2 years of treatment \[for nivolumab\] whichever occurs first. |
| Tivozanib | EXPERIMENTAL | Subjects with advanced RCC will receive 1.34 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug until disease progression or unacceptable toxicities occur, or other withdrawal criteria are met. |
| Name | Type | Description |
|---|---|---|
| Tivozanib | DRUG | Tivozanib will be administered orally. |
| Nivolumab | DRUG | Nivolumab will be administered via intravenous infusion. |
Inclusion Criteria: * Radiographic disease progression during or following at least 6 weeks of treatment with ICI for locally advanced or metastatic RCC with a clear cell component either in first- or second-line treatment. * Subjects must have recovered from the adverse events of prior therapy to ...